Safety and Efficacy of the Cochlear Nucleus CI422 Cochlear Implant in Adults

Clinical study to evaluate the safety and efficacy of the Cochlear™ Nucleus® CI422 cochlear implant for new cochlear implant adult recipients with broader requirements to be considered an eligible candidate.

Study Overview

• Status: Completed
• Conditions: Hearing Loss
• Intervention / Treatment: Device: Nucleus CI422 Cochlear Implant with N6 Sound Processor

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21204
      • Greater Baltimore Medical Center
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • University of North Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Eighteen years of age or older at the time of implantation
2. Moderate low frequency thresholds up to and including 1000 Hz, severe to profound high frequency (above 3000 Hz) sensorineural hearing loss
3. Minimum of 30 days experience with appropriately fit bilateral amplification, fit using the standardized National Acoustics Laboratory (NAL) fitting method described in the Fitting and Use of Hearing Aids section below
4. Aided Consonant Nucleus Consonant (CNC) word recognition score (mean of two lists) between 10% and 50%, inclusive in the ear to be implanted
5. Aided CNC word recognition score (mean of two lists) in the contralateral ear equal to, or better than, the ear to be implanted but not more than 70%
6. Willingness to use bimodal stimulation (i.e., a cochlear implant on one ear and a hearing aid on the contralateral ear) through at least 6-months postactivation
7. English spoken as a primary language

Exclusion Criteria:

1. Duration of severe-to-profound hearing loss greater than 30 years
2. Congenital hearing loss (for the purpose of this study, onset prior to 2 years-of-age)
3. Medical or psychological conditions that contraindicate undergoing surgery as determined by the Investigator
4. Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
5. Conductive overlay of 15 decibels (dB) or greater at two or more frequencies, in the range 500 to 1000 Hz
6. Deafness due to lesions of the acoustic nerve or central auditory pathway
7. Absence of cochlear development
8. Diagnosis of auditory neuropathy
9. Active middle-ear infection
10. Tympanic membrane perforation in the presence of active middle ear disease
11. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices as determined by the Investigator
12. Unwillingness or inability of the candidate to comply with all investigational requirements as determined by the Investigator
13. Additional handicaps that would prevent or restrict participation in the audiological evaluations as determined by the Investigator

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Nucleus CI422 Cochlear Implant with Nucleus 6 (N6) Sound Processor	Device: Nucleus CI422 Cochlear Implant with N6 Sound Processor

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Open Set Monosyllabic Word Recognition Score as Measured on a Consonant Nucleus Consonant (CNC) Word Test	Performance at 6 months postactivation compared to pre-operative word recognition score (percent correct: 0-100%, where a 0% is the lowest score and a 100% is the highest score)	Preoperative baseline to 6 months postactivation

Collaborators and Investigators

• Sponsor: Cochlear

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: May 29, 2013
• First Submitted That Met QC Criteria: May 29, 2013
• First Posted (Estimate): June 3, 2013

Study Record Updates

• Last Update Posted (Actual): January 25, 2021
• Last Update Submitted That Met QC Criteria: January 5, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss
• Other Study ID Numbers: CAM-CI422-2012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes